Device for attaching, relocating and reinforcing tissue and methods of using same

ABSTRACT

A device for attaching, relocating or reinforcing tissue includes a first tissue anchoring portion having a support plate and a plurality of barbs extending from the support plate for engaging tissue at a first location, a second tissue anchoring portion having a support plate and a plurality of barbs extending from the support plate for engaging tissue at a second location which is different from the first location, and a connection element, such as a suture or a mesh structure, interposed between and interconnecting the first tissue anchoring portion and the second tissue anchoring portion. The support plate of at least one of the first tissue anchoring portion and the second tissue anchoring portion may have longitudinally axially formed therethrough a bore for receiving the connecting element so that the surgeon may pull on the end of the connecting element to adjust the distance between the first tissue anchoring portion and the second tissue anchoring portion.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to surgical devices forrelocating and fixating soft tissue, and more particularly relates to asoft tissue anchoring device for attaching, relocating or reinforcingtissue, such as used in facial plastic surgery.

2. Description of the Prior Art

In many types of surgery, there is a need to suspend soft tissue orrelocate the tissue from one position to another. This is often donewith sutures, but sutures can pull through the tissue and can bedifficult to secure to the tissue by tying knots.

Soft tissue anchors are also well known in the art and are used indifferent surgical procedures. For example, U.S. Pat. No. 6,645,226,which issued to Daniel Jacobs and Dirk Thye, and U.S. Pat. No.6,485,503, which issued to Daniel Jacobs and Robert James Elson, thedisclosures of which are incorporated herein by reference, disclose oneform of a tissue approximation device and method for using the device,wherein the device is an implantable, biodegradable construct that isused to attach one tissue structure to another but requires the presenceof natural tissue structures to achieve the desired lift. For example,the aforementioned U.S. Pat. No. 6,645,226 to Jacobs et al. describes amethod where the periosteum in a patient's forehead is detached and thenrelocated by the surgeon. It is then held in place with the implantabletissue anchor disclosed in the patent. The aforementioned U.S. Pat. No.6,485,503 to Jacobs et al. discloses a similar tissue anchoring device.

The problems with such tissue anchoring devices disclosed in theaforementioned Jacobs et al. patents include the fact that the describedtissue anchors cannot be implanted and then adjusted afterwards; thetissue anchors and the adjustment of the anchors to provide the desiredlift must be done in a single step. Additionally, the tissue anchorsdisclosed in the aforementioned Jacobs et al. patents require thesurgical creation of a rather large tunnel or elevated flap of tissue inorder to relocate the tissue.

OBJECTS AND SUMMARY OF THE INVENTION

It is an object of the present invention to provide a device forattaching, relocating or reinforcing tissue and methods of using such adevice.

It is another object of the present invention to provide a device foranchoring to and relocating a variety of tissue types and which issuitable for use in many different body locations and surgicalprocedures.

It is still another object of the present invention to provide a devicewhich can relocate and fixate tissue in a minimally invasive manner.

It is a further object of the present invention to provide a devicewhich can relocate and fixate tissue and which may be adjusted by thesurgeon after being surgically implanted.

It is yet a further object of the present invention to provide a devicefor anchoring to and relocating tissue which allows the physician to setthe tissue engaging structures of the device first and then subsequentlyadjust the locations of or spacing between the tissue engagingstructures.

It is yet another object of the present invention to provide a devicefor anchoring to and relocating tissue whereby the amount of tissuerelocation may be controlled by the surgeon at the time of placement ofthe device in a patient's body.

It is still a further object of the present invention to provide adevice for anchoring to and relocating tissue which may be implanted ina patient's body in open, endoscopic and blind surgical procedures.

It is yet another object of the present invention to provide a devicefor attaching, relocating or reinforcing tissue and methods for usingsuch a device which overcome the inherent disadvantages of known devicesand methods.

In accordance with one form of the present invention, a device forattaching, relocating or reinforcing tissue includes at least two tissueengagement means, including a first tissue engagement means and a secondtissue engagement means, and a connection means interposed between andinterconnecting the first tissue engagement means and the second tissueengagement means. The first tissue engagement means is located at thesite of the tissue to be relocated. The second tissue engagement meansis situated at the anchor site. Preferably, the device is adjustable sothat the amount of displacement of the tissue may be controlled by thesurgeon during the surgical implantation of the device. The first andsecond tissue engagement means, and the connection means, may be formedfrom either resorbable or non-resorbable material, and the resorptionprofile, stiffness, strength and other mechanical and materialproperties of the device may be tailored to meet the specific needs andobjectives of the surgeon.

These and other objects, features and advantages of the presentinvention will be apparent from the following detailed description ofillustrative embodiments thereof, which is to be read in connection withthe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram showing generically the three basic componentsof a device for attaching, relocating or reinforcing tissue formed inaccordance with one form of the present invention.

FIG. 2A is a perspective view of a device for attaching, relocating orreinforcing tissue formed in accordance with a second form of thepresent invention.

FIG. 2B is a cross-sectional view of the device of the present inventionshown in FIG. 2A.

FIG. 2C is a pictorial illustration of the device of the presentinvention shown in FIGS. 2A and 2B implanted in a patient during facialplastic surgery, and illustrating a method for using the device of thepresent invention.

FIG. 3A is a perspective view of a device for attaching, relocating orreinforcing tissue formed in accordance with a third form of the presentinvention.

FIG. 3B is a cross-sectional view of the device of the present inventionshown in FIG. 3A.

FIG. 3C is a cross-sectional view of a portion of the device of thepresent invention shown in FIGS. 3A and 3B.

FIG. 4 is a perspective view of a device for attaching, relocating orreinforcing tissue formed in accordance with a fourth form of thepresent invention.

FIG. 5 is a cross-sectional view of the device of the present inventionshown in FIG. 4A.

FIG. 6 is a perspective view of a device for attaching, relocating orreinforcing tissue formed in accordance with a fifth form of the presentinvention.

FIG. 7 is a perspective view of a device for attaching, relocating orreinforcing tissue formed in accordance with a sixth form of the presentinvention.

FIG. 8 is a perspective view of a device for attaching, relocating orreinforcing tissue formed in accordance with a seventh form of thepresent invention.

FIG. 9 is a perspective view of a device for attaching, relocating orreinforcing tissue formed in accordance with an eighth form of thepresent invention.

FIG. 9A is a cross-sectional view of a portion of the device of thepresent invention shown in FIG. 9.

FIG. 10 is a perspective view of a device for attaching, relocating orreinforcing tissue formed in accordance with a ninth form of the presentinvention.

FIG. 11A is a perspective view of a first form of a tissue engagementmeans of a device for attaching, relocating or reinforcing tissue formedin accordance with the present invention.

FIG. 11B is a perspective view of a second form of a tissue engagementmeans of a device for attaching, relocating or reinforcing tissue formedin accordance with the present invention.

FIG. 11C is a perspective view of a third form of a tissue engagementmeans of a device for attaching, relocating or reinforcing tissue formedin accordance with the present invention.

FIG. 11D is a perspective view of a fourth form of a tissue engagementmeans of a device for attaching, relocating or reinforcing tissue formedin accordance with the present invention.

FIG. 11E is a perspective view of a fifth form of a tissue engagementmeans of a device for attaching, relocating or reinforcing tissue formedin accordance with the present invention.

FIG. 12 is a cross-sectional view of a pictorial illustration of thedevice of the present invention shown in FIG. 10 being implanted in apatient's heart to provide support for patients experiencing dilatedcongestive heart failure.

FIG. 13 is a cross-sectional view of a pictorial illustration of thedevice of the present invention shown in FIG. 10 being implanted in apatient to support the patient's vagina in pelvic organ prolapse repair.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring initially to FIG. 1 of the drawings, it will be seen that,generically, a device for attaching, relocating or reinforcing tissueconstructed in accordance with one form of the present inventionincludes at least two tissue engagement means, and a connection meansinterposed between and interconnecting the two tissue engagement means.The device of the present invention may include more than two tissueengagement means, such as the three tissue engagement means of thedevice of the present invention shown in FIG. 10, which will bedescribed in greater detail. The first tissue engagement means 2, whichis also designated as “Part A” in FIG. 1, is a tissue anchoring portionof the device that is typically located at the tissue site to bemanipulated (e.g., moved). The second tissue engagement means 4, alsoreferred to in FIG. 1 as “Part B”, is another tissue anchoring portionof the device that is typically located at the anchor site. The thirdprimary component of the device of the present invention, which is alsolabeled as “Part C” in FIG. 1, is the connection means 6 which isinterposed between and connects the first tissue engagement means 2 andthe second tissue engagement means 4. Part C, the connection means 6,could not only be used as an interconnection between the first andsecond tissue anchoring portions 2, 4, but may also be used to providetissue support, as will be evident from the detailed description of thevarious embodiments of the present invention to follow.

One form of the device of the present invention is illustrated by FIGS.2A-2C. Part A, the tissue anchoring portion 2 which is located at thetissue site to be manipulated, is a barbed, resorbable anchor preferablyconstructed to include a planar support plate 8 and a plurality of barbs10 extending outwardly from an exposed surface of the support plate 8and at an angle thereto, which is preferably between about 30 degreesand about 60 degrees, but is even more preferably at a 45 degree angle,between the barbs and the surface of the support plate 8 from which theyextend. One form of material that is resorbable that may be used in theconstruction of the first tissue engagement means 2, i.e., the “Part A”tissue anchoring portion, is polydioxanone, as an example, but it isenvisioned to be within the scope of the present invention to form the“Part A” tissue anchoring portion from other resorbable materials, suchas those that will be described later in greater detail.

When anchoring soft tissue to bone or periosteum, the second tissueengager is preferably a bone anchor. Otherwise, they can just be likethe first tissue anchor. More specifically, the second tissue engagementmeans 4, that is, the “Part B” tissue anchoring portion of the device ofthe present invention, is preferably formed as a bone anchor, such asthe Biofastin RC threaded suture anchor manufactured by DePuy Mitek ofNorwood, Mass., which has a bore formed through it to allow a suture topass therethrough. The bone anchor is situated opposite the first tissueanchoring portion 2. A suture 12, preferably made from polypropylene, isthe connection means 6, i.e., the “Part C” of the device of the presentinvention shown generically in FIG. 1, which connects the barbed,resorbable tissue anchoring portion 2 with the Mitek bone anchor 4.

The embodiment of the present invention shown in FIG. 2A and 2B isparticularly suitable for use in relocating the tissues of the midfaceof a patient by placing the barbed tissue anchoring portion 2 in themalar fat pad, and placing the bone anchor 4 in the skull above thetemporal region, as illustrated by FIG. 2C, with the suture 12 extendingbetween and connecting the two tissue anchoring portions 2,4. Thesurgeon would implant both tissue anchors, and then pull on the suture12 to adjust the location of the fat pad.

A third form of a device for relocating tissue, constructed inaccordance with the present invention, is shown in FIGS. 3A-3C. Here,two preferably permanent (i.e., non-resorbable) first and second tissueanchoring portions 2,4 (i.e., “Part A” and “Part B” shown in FIG. 1) arejoined together with a permanent suture 12 preferably made frompolypropylene (i.e., the “Part C” connection means). The “Part A” softtissue anchoring portion 2 includes a support plate 8 having an exposedsurface from which angularly and outwardly extend relatively large barbs10 (i.e., relative to the “Part B” strong tissue anchoring portion 4).The barbs 10 extend from the surface of the support plate 8 atpreferably an angle of between about 30 degrees and 60 degrees, and morepreferably, 45 degrees, in the direction of the Part B strong tissueanchoring portion 4. The soft tissue anchor 2 is fixedly joined to thepolypropylene suture 12.

The strong tissue anchoring portion (i.e., the “Part B” tissueengagement means 4) may be in the form of a smaller support plate 14than that of the soft tissue anchoring portion 2 longitudinally throughwhich is formed an axial bore 16. Through the axial bore 16 passes thesuture 12. Preferably, the axial bore 16 allows the suture 12 to movetherethrough in one direction only, that is, away from the soft tissueanchoring portion 2. Structure to permit uni-directional movement of thesuture 12 through the strong tissue anchoring portion 4 may include, forexample, ratchet teeth 18 extending from diametrically opposite sides ofthe bore 16 and radially into the bore to closely engage the suture 12,as shown in FIG. 3C. The ratchet teeth 18 of one side are in mirroredsymmetry to the ratchet teeth 18 of the other, and both are angledinwardly of the bore 16 and away from the soft tissue anchoring portion2. With such structure, the suture 12 may slip past the ratchet teeth 18in one direction only, that is, away from the soft tissue anchoringportion 2, and the ratchet teeth 18 will exert a force or grip on thesuture 12 to prevent its movement in the opposite direction (i.e.,toward the soft tissue anchoring portion 2).

The support plate 8 of the soft tissue anchoring portion 2 also includesan exposed surface from which extend a plurality of barbs 10 which areangled from the surface from which they extend at, again, preferablybetween about 30 degrees and about 60 degrees, and more preferably about45 degrees. Also, depending on the surgical application, the barbs 10 ofthe strong tissue anchoring portion 4 extend in a direction opposite tothat of the barbs 10 of the soft tissue anchoring portion 2.Furthermore, the barbs 10 of the strong tissue anchoring portion 4 arepreferably smaller than those of the soft tissue anchoring portion 2.

The soft tissue anchoring portion 2, with the relatively large barbs 10,is designed for location in the soft tissues of the face and providesgood “pullout” strength in fat, while the strong tissue anchoringportion 4, with its relatively smaller barbs 10, is designed to beanchored in stronger tissues, such as the temporalis fascia, or beneaththe periosteum. Either one or both of the soft tissue anchoring portion2 and the strong tissue anchoring portion 4 may be made from aresorbable material.

The anchoring portions 2,4 of the embodiment of the present inventionshown in FIGS. 3A-3C may be surgically implanted in either an open,endoscopic or blind procedure. In the preferred procedure, the surgeonwould use a trans-buccal approach under direct visualization to placethe soft tissue anchoring portion 2 in the malar fat pad. Morespecifically, a hollow needle would be blindly inserted through thesubcutaneous cheek tissue and up into the temple of the temporalisfascia through a small incision under direct visualization. The suture12 would then be adjusted until the fat pad is in the desired andappropriate position, and then it would be tied off. Alternatively, thetemporalis fascia anchoring portion 4 could incorporate a suturegripping means, such as the ratchet teeth 18 described previously, sothat the suture 12 would not require a knot. Although the ratchet teeth18 was described as one form of suture gripping means, it is envisionedthat other means could be employed, including a pre-tied knot, afriction locking collar, a crimped-on staple or any other means known tosecure a suture, filament, line, string or rope, for example, to acleat, clamp or other securing device.

A fourth embodiment of a tissue anchoring, relocating or reinforcingdevice formed in accordance with the present invention is shown in FIGS.4 and 5. The “Part B” tissue engagement means 4, i.e., a tissueanchoring portion that is located at the anchoring site, includes asupport plate 8 having an exposed surface from which outwardly extends aplurality of angled barbs 10. The barbs 10 are preferably angled to thesame degree as previously described with respect to the otherembodiments of the present invention. A single bore or two separateparallel bores 16 extend longitudinally axially through the thickness ofthe support plate 8. A pair of sutures 12 are received by and passthrough the single or separate parallel bores 16. This support plate 8may include suture gripping means, such as the ratchet teeth 18previously described, or a friction locking collar, crimped-on staple orother means to provide one-way movement of the suture 12 through thesupport plate of the tissue anchoring portion.

A “Part A” tissue anchoring portion 2, i.e., the one that is located atthe site to be manipulated, is also included. This anchoring portion 2includes a support plate 8 having an exposed surface from whichoutwardly extends a plurality of angled barbs 10. Again, the barbs 10extend preferably at the same preferred angle as the barbs 10 previouslydescribed with respect to the other embodiments of the presentinvention. Also, the barbs 10 extend from the support plate 8 of the“Part A” tissue anchoring portion 2 in a direction which is opposite tothat of the barbs 10 of the “Part B” tissue anchoring portion 4. Also,depending on the particular surgical procedure and application of thedevice, the barbs 10 of this anchoring portion 2 may extend from a sideof the support plate 8 which is in an opposite facing direction to theside of the support plate 8 of the other anchoring portion 4 from whichthe barbs 10 extend. The two sutures 12 are fixedly joined to thesupport plate 8 of this tissue anchoring portion 2.

The “Part A” tissue anchoring portion 2 is designed to grip strongtissues, such as ligaments and other connective tissue, tendons, musclefascia and periosteal fascia, and the “Part B” tissue anchoring portion4 is designed to be anchored in other strong tissues, such as beneaththe temporalis fascia. The two anchoring portions 2,4 are connected bythe sutures 12. In a test procedure that demonstrated the suitability ofthe fourth embodiment of the present invention for facial plasticsurgery, the “Part A” anchoring portion 2 was placed in a cadaver'smaxillo-buccal ligament through an open approach. A small incision wasmade above the left ear of the cadaver, and forceps were insertedblindly subcutaneously through the cheek tissue of the patient; then,the sutures 12 were brought through the cheek tissue. The “Part B”anchoring portion 4 was inserted through a small open incision placedbeneath the temporalis fascia, and the first anchoring portion 2 wasthen adjusted by pulling the sutures 12 and tying them off. The locationand dissection path of the anchoring device of the present invention areshown in FIG. 5 of the drawings. It should be noted that the opendissection of the cheek tissue was only performed for experimentalpurposes. The preferred method of placement of the device is through anendoscopic tunnel that begins at the temporal incision.

It is envisioned as part of the present invention to form the firsttissue engagement means 2, i.e., the “Part A” tissue anchoring portion,and the connection means 6, the “Part C” component, or the second tissueengagement means 4, i.e., the “Part B” tissue anchoring portion, and the“Part C” connection means 6, as a single unitary piece. For example, ifthe connection means 6 and the second tissue engagement means 4 wereformed from a mesh material, and the connection means 6 and/or the firsttissue engagement means 2 were adjustable in distance from the secondtissue engagement means 4, then such a device may be suitable for use asa malar fat pad relocation device. Such a device formed in this manneris shown schematically in FIG. 6.

More specifically, FIG. 6 shows an elongated connection means formed asa strip 20 of mesh material which is connected to the second tissueengagement means 4 (i.e., the “Part B” tissue anchoring portion), whichis also formed from a mesh material. The second tissue anchoring portion4 is shown in a “spider web” configuration, that is, generally roundwith concentrically disposed circular strands 22 joined to radiallyextending strands 24. Of course, it is envisioned to be within the scopeof the present invention to form the “Part B” tissue anchoring portion 4in other shapes and configurations from that which is shown in FIG. 6and described previously. The elongated mesh connection means 20 isattached to a “Part A” tissue engagement means 2, or first tissueanchoring portion, which is used to attach and secure to the device softtissue. The soft tissue anchoring portion 2 may be formed in a similarmanner to those of the other embodiments of the present inventionpreviously described such that it includes a support plate 8 having anexposed surface from which outwardly extends a plurality of angled barbs10, the barbs 10 preferably extending from the surface of the supportplate at an angle of preferably between about 30 degrees and about 60degrees, and more preferably at about 45 degrees. The elongated meshstrip 20 which serves as the connection means may pass through a bore 16which extends longitudinally axially through the center of the supportplate 8 of the soft tissue anchoring portion 2 and may engage grippingmeans inside the bore, such as the ratchet teeth 18 described withrespect to the earlier embodiment shown in FIGS. 3A-3C, to allow aone-way movement of the mesh connection strip 20 through the soft tissueanchoring portion 2. Of course, other gripping means may be suitable foruse with the present invention, such as a pre-tied knot formed in themesh connection strip 20, a friction locking collar or a crimped-onstaple or other means, such as described previously. Alternatively, nogripping means may be included, and the surgeon simply ties off with aknot the end of the mesh connection strip 20 as it passes through thesupport plate 8 of the soft tissue anchoring portion 2.

Thus, the mesh connection strip 20 could either be extendable orinextendable through the first tissue anchoring portion 2, depending onthe desired characteristics of the device and the requirements of thesurgeon for the particular surgical application. For example, if thedevice is made extendable (i.e., adjustable in length), and if thestiffiess of the device is tailored to the particular application, suchas by using a thicker mesh or a mesh material which is less flexible,the device may be provided with properties that will exert a force onthe tissue that will keep the tissue taut as it heals. An additionaladvantage of the second tissue anchoring portion (i.e., the “Part B”tissue engagement means 4) being formed of a mesh material is that itwill allow a much smaller entry profile for the device during surgicalimplantation, as it may be rolled up during the surgical procedure.

Alternatively, the device of the present invention may be formed fromtwo barbed anchoring portions (i.e., a “Part A” and “Part B” tissueengagement means 2,4) interconnected by an elongated mesh strip 20serving as the “Part C” connection means 6, as shown in FIG. 7 of thedrawings. Each of the two barbed anchoring portions 2,4 preferablyincludes a support plate 8 having an exposed surface from which aplurality of angularly-disposed barbs 10 outwardly extend. The meshconnection strip 20 may be fixedly joined to and between the supportplate 8 of each of the two barbed anchoring portions 2,4 or,alternatively, may pass through longitudinally axially extending bores16 formed in one or both of the barbed anchoring portions 2,4 so thatthe mesh connection strip 20 can be adjusted with respect to one or bothof the anchoring portions 2,4 in order to adjust the distance betweenthe anchoring portions during the surgical implantation procedure, inthe same manner as described previously with respect to the embodimentshown in FIG. 6 of the drawings. Again, gripping means, such asdescribed previously with respect to the embodiment shown in FIG. 6, maybe included in one or both of the barbed anchoring portions 2,4 topermit only unidirectional movement of the mesh connection strip 20 inopposite directions through each respective anchoring portion. Theembodiment shown in FIG. 7, having preferably an adjustable meshconnection strip 20 with two barbed anchoring portions 2,4, could findutility in supporting the soft tissues of the neck.

Another embodiment of the present invention is a variation of that shownin FIG. 6 of the drawings. In particular, this embodiment includes abarbed anchoring portion, defining a “Part A” soft tissue engagementmeans 2, at one end of the device, a section of mesh material 26, suchas the “spider web” configured structure of the embodiment shown in FIG.6, as the second tissue anchoring portion (i.e., a “Part B” tissueengagement means 4), and a suture 12 interposed between andinterconnecting the two tissue anchoring portions 2, 4. The soft tissueanchoring portion 2, again, may be formed with a support plate 8 havingan exposed surface from which angularly extend a plurality of barbs 10to engage the soft tissue of the patient and may include alongitudinally axially extending bore 16 through which the suture 12passes, and gripping means, such as ratchet teeth 18 internal to thebore, such as described with respect to the embodiments shown in FIGS.3A-3C to allow the distance between the anchoring portions 2,4 to beadjusted by the surgeon pulling on the end of the suture 12 which passesthrough the soft tissue anchoring portion 2 of the device, with onlyone-way directional movement being permitted by the gripping means sothat the suture 12, defining the connection means 6, does not loosen andthe selected distance between the two anchoring portions 2,4 does notchange after the surgical procedure has been completed. Again, othergripping means, such as described previously in the other embodiments,may be used in the device of the present invention shown in FIG. 7.Alternatively, no gripping means need be included, and the surgeonsimply ties a knot in the end of the suture 12 which passes through thesoft tissue anchoring portion 2 to prevent the suture 12 from slippingback through the bore 16 of the anchoring portion 2. This embodiment ofthe present invention shown in FIG. 7 is particularly useful in facialplastic surgery, because the profile of the connection element 6 is keptto a minimum and, therefore, the damage that needs to be done to implantthe device is minimized.

Another adjustable embodiment of the present invention is shown in FIGS.9 and 9A of the drawings. Here, two barbed anchoring portions (i.e., a“Part A” and “Part B” tissue engagement means 2,4), each preferablyhaving a support plate 8 with an exposed surface from which outwardlyand angularly extends a plurality of barbs 10 to engage the tissue ofthe patient, are connected with a ratcheting connection element (i.e.,the “Part C” connection means 6). More specifically, either one of thetwo barbed anchoring portions (as shown in FIG. 9, for example, the“Part A” soft tissue engagement means 2) may be fixedly joined to theconnection element, and the other of the barbed anchoring portions (asshown in FIG. 9, for example, the “Part B” tissue engagement means 4)may be adjustably joined to the connection element 6. Even morespecifically, the “Part B” tissue engagement means 4 preferably includesa support plate 8 having a plurality of barbs 10 extending angularly andoutwardly from an exposed surface thereof, and a slot 28 formedlongitudinally axially therethrough for receiving the ratchetingconnection element 6, as shown in FIG. 9A. Extending at least partiallyinto the slot 28 formed in the tissue anchoring portion 4 is a resilientpawl 30.

The connection element 6 is preferably formed as a flexible orsemi-flexible elongated thin strip of material having opposite lateraledges 32 on at least one of which is formed a plurality of ratchet teeth34. As shown in FIG. 9A, the ratchet teeth 34 of the connection element6 engages the resilient pawl 30 of the tissue anchoring portion 4 toallow the distance between the two barbed anchoring portions 2,4 to beadjusted by the surgeon pulling on the end of the connection element 6which passes through the axial slot 28 of the tissue anchoring portion4. The engagement of the pawl 30 with the ratchet teeth 34 permits onlyuni-directional movement of the connection element 6 through the tissueanchoring portion 4 to prevent slippage of the connection element in anopposite direction so that the distance between the two tissue anchoringportions 2,4 does not change after being adjusted by the surgeon toobtain the desired results. This avoids the need for the surgeon to tieknots in a suture when performing a tissue relocation procedure.

FIG. 10 shows another embodiment of a device formed in accordance withthe present invention for attaching, relocating or reinforcing tissue.In this particular embodiment, the connecting element (the “Part C”connection means 6) may be formed as a mesh 36 or from a mesh materialthat has multiple arms 38 extending in different directions. As shown inFIG. 10, the mesh connecting element 36 has three arms 38 extending inthree different directions to define a triangular web for supportingtissue, although it is envisioned to be within the scope of the presentinvention to provide a connecting element 36 that extends in moredirections and having more arms 38 than that shown in FIG. 10. Each ofthe arms 38 of the mesh connecting element 36 is connected to arespective anchoring portion 40 of the device, either a “Part A” tissueengagement means 2 or a “Part B” tissue engagement means 4. Also, eachof the arms 38 may be adjustably connected to one of the tissueanchoring portions 40 so that appropriate tension is provided to thetissue supported by the mesh connecting element 36. The tissue anchoringportions 40 may be in the form of the barbed anchors previouslydescribed with respect to several other embodiments of the presentinvention, for example, one or the other of the tissue anchoringportions 2,4 shown in FIGS. 3A-3C, FIG. 6 or FIG. 7. More specifically,each of the tissue anchoring portions 40 may include a support plate 8having an exposed surface from which angularly outwardly extend aplurality of barbs 10, such as described previously, with the supportplate 8 having formed longitudinally axially therethrough a bore 16. Thearms 38 of the connecting element 36 themselves may pass directlythrough the axial bores 16 of the support plates 10 of the tissueanchoring portions 40, or they may be connected to sutures 12 which passthrough the bores 16 of the support plates 10. Again, like the otherembodiments, the tissue anchoring portions 40 may include grippingmeans, such as ratchet teeth 18, formed in the axial bore 16 of theirrespective support plates 40 to allow one-way adjustment of the meshconnecting element 36 and to prevent slippage thereof through the tissueanchoring portions. Or, alternatively, one or more of the arms 38 of themesh connecting element 36 may be fixedly joined to a respective tissueanchoring portion 40 of the device.

The embodiment shown in FIG. 10 and described previously is particularlyuseful in supporting large structures, like the breast, during breastreduction surgery, or the vaginal vault during pelvic floor repair. Inthis latter case, two of the arms 38 would be placed anterior andposterior to the vagina, in the space between the vagina and the urethraand the space between the vagina and the rectum respectively. Theremaining arm 38 would then be placed deep in the patient's body, to beanchored to the periosteum near the sacrum. More specifically, FIG. 13illustrates the location of the device having a mesh connection element36 with multiple arms 38 implanted in a patient to provide support tothe vagina in pelvic organ prolapse repair. More specifically, FIG. 13shows the preferred deployment of the embodiment of FIG. 10, with themesh 36 placed anterior and posterior to the vagina through atransvaginal incision or through an endoscopic approach, with theanchors 40 set near the entroitus and into the sacrospinus ligament orthe periosteum near the sacrum. The arms 38 of the mesh connectingelement 36 are then adjusted by the surgeon to provide the appropriateplacement of the vaginal vault.

The embodiment of the present invention shown in FIG. 10 is alsosuitable for use for patients with congestive heart failure. In thissituation, and as illustrated by FIG. 12 of the drawings, one tissueanchoring portion 40 of the device would be placed at the apex of theheart, on the anterior surface, and the other two tissue anchoringportions 40 would be placed in the atrio-ventricular septum, as shown inFIG. 12. The surgeon would then adjust the mesh connecting element 36with respect to the anchoring portions 40 until the appropriate level ofventricular volume change is achieved.

Primarily, throughout this disclosure of the present invention, tissueanchoring portions of the device of the present invention, in thevarious embodiments, have been described as having support plates 8 withangular barbs 10 extending therefrom, in order to facilitate anunderstanding of the present invention and to describe one form oftissue engagement means which is suitable for use. However, it isenvisioned to be within the scope of the present invention to havetissue anchoring portions of the device formed with other structure thatis capable of attaching to either soft or hard tissue. FIGS. 11A-11Eshow other forms of tissue engagement means 2,4, either of the “Part A”or “Part B” type, that are suitable for use with the device of thepresent invention and are envisioned to be within the scope of thepresent invention.

More specifically, FIG. 11A shows the tissue anchoring portion having asupport plate 8 with angularly disposed barbs 10 extending from anexposed surface thereof, such as described previously with respect tomany of the embodiments shown in the figures. These barbs 10 are shownto extend in the direction of the force applied, such as when theconnecting element is tightened. The arrow F shown in FIG. 1 A denotesthe direction of the force applied against the tissue anchoring portion,and the angle of the barbs 10 extending therefrom resists such force.

FIG. 11 B shows an alternative form of a tissue anchoring portion,either of the “Part A” type or the “Part B” type. Here, the tissueanchoring portion may be formed as a plate-like structure 42 which canbe said to be tree-shaped in plan view, having opposite lateral edges 44with a plurality of barbs 46 extending outwardly from each lateral edge44. Unlike the “out of plane” barbs 10 of the tissue anchoring portionshown in FIG. 11A, the tissue anchoring portion of FIG. 1 B has “inplane” barbs 46. The barbs 46 extend angularly from the lateral edges 44in a direction toward the force F applied against the tissue anchoringportion to oppose such force exerted by the connecting element 6 joinedto the tissue anchoring portion of the device.

Alternatively, the tissue anchoring portion of the device may include“in plane” and “out of plane” barbs, such as shown in FIG. 11C. Morespecifically, a thin, flat planar member 48 having opposite lateraledges 50, with barbs 52 extending angularly outwardly from the lateraledges 50, as in the embodiment shown in FIG. 11B, may further haveangularly protruding barbs 54 extending outwardly from the opposite topand bottom sides 56,58 of the planar member 48. Again, the barbs 52formed on the lateral edges 50 and the barbs 54 formed on the top andbottom sides 56,58 are angularly disposed in the direction of the forceF applied against the tissue anchoring portion in order to oppose suchforce.

It is further contemplated that the tissue anchoring portions of thedevice could be T-shaped, such as shown in FIG. 11D, with outwardlyextending legs 60 joined to the connection element 6 which may be asuture or mesh or take on another form. Again, alternatively, the tissueanchoring portion may be in the form of a large bead or sphere 62 at theend of the connection means 6, such as shown in FIG. 11E, that preventsthe tissue anchoring portion of the device from pulling through thetissue to which it is attached.

Alternatively, the tissue anchoring portions 2,4 of the device may besewn in place, glued in place with a biocompatible adhesive, such as afibrin glue, or implanted and fixed in position through the ingrowth oftissue. It is also possible to make the mesh connective element (the“Part C” connection means 6), such as that shown in FIG. 9 of thedrawings, self-adhesive by coating it with fibrin or thrombin andallowing it to “clot” into place.

Furthermore, the tissue anchoring portions 2,4 of the device of thepresent invention may be made out of a variety of materials, includingresorbable plastics like PLA (poly lactic acid), PGA (poly glycolicacid) and polydioxanone, or non-resorbable plastics, such as nylon,polyester and others. The tissue anchoring portions 2,4, either one orboth of the “Part A” or “Part B” type, may also be formed from aresorbable metal, such as magnesium, or permanent metals, such asstainless steel and nickel-titanium alloys.

The connecting element (i.e., the “Part C” connection means 6) which isinterposed between the two tissue anchoring portions 2,4 may be formedfrom sutures, a mesh, molded strips or metal. The materials of theconnecting element could be selected to be resorbable, such as PLA, PGA,magnesium and others, or non-resorbable, such as stainless steel,nickel-titanium, titanium and others.

Various applications of the device of the present invention forattaching, relocating or reinforcing tissue have been described herein.However, it should be understood that the invention is useful in avariety of procedures where the suspension or reattachment of softtissue is required. These procedures include “facelift” procedures,particularly for the upper and midface, and other facial cosmeticsurgery, such as neck and jowl lifts. The device of the presentinvention could also be used to provide support in breast surgery (e.g.,breast lift or mastopexy), testicular lift procedures and repair ofinguinal hernias. The device of the present invention may also be usedto provide support to incompetent venous valves in patients sufferingfrom varicose veins by wrapping the vein in the area of the valve andreshaping the valve until it closes appropriately.

Although illustrative embodiments of the present invention have beendescribed herein with reference to the accompanying drawings, it is tobe understood that the invention is not limited to those preciseembodiments, and that various other changes and modifications may beeffected therein by one skilled in the art without departing from thescope or spirit of the invention.

1. A device for attaching, relocating or reinforcing tissue, whichcomprises: at least two tissue engagement means, including a firsttissue engagement means and a second tissue engagement means; andconnection means interposed between and interconnecting the first tissueengagement means and the second tissue engagement means.
 2. A device forattaching, relocating or reinforcing tissue as defined by claim 1,wherein the connection means slidably engages at least one of the firsttissue engagement means and the second tissue engagement means to allowthe distance between the first tissue engagement means and the secondtissue engagement means to be adjusted.
 3. A device for attaching,relocating or reinforcing tissue as defined by claim 1, wherein at leastone of the first tissue engagement means and the second tissueengagement means includes a support plate having an exposed surface, anda plurality of barbs extending angularly outwardly from the exposedsurface.
 4. A device for attaching, relocating or reinforcing tissue asdefined by claim 3, wherein the barbs extend from the exposed surface ofthe support plate at an angle thereto of between about 30 degrees andabout 60 degrees.
 5. A device for attaching, relocating or reinforcingtissue as defined by claim 3, wherein the barbs extend outwardly fromthe exposed surface of the support plate at an angle of about 45 degreesthereto.
 6. A device for attaching, relocating or reinforcing tissue asdefined by claim 3, wherein the support plate further has formedlongitudinally axially therethrough a bore for receiving the connectionmeans therethrough.
 7. A device for attaching, relocating or reinforcingtissue as defined by claim 6, wherein the support plate includes ratchetteeth extending into the axial bore for engaging the connection meansand to prevent movement of the connection means with respect to thesupport plate in at least one direction.
 8. A device for attaching,relocating or reinforcing tissue as defined by claim 1, wherein at leastone of the first tissue engagement means and the second tissueengagement means includes gripping means for engaging the connectionmeans and preventing movement of the connection means with respect tothe at least one of the first tissue engagement means and the secondtissue engagement means in at least one direction.
 9. A device forattaching, relocating or reinforcing tissue as defined by claim 1,wherein the connection means includes at least one suture extendingbetween the first tissue engagement means and the second tissueengagement means.
 10. A device for attaching, relocating or reinforcingtissue as defined by claim 1, wherein the connection means includes amesh structure extending between the first tissue engagement means andthe second tissue engagement means.
 11. A device for attaching,relocating or reinforcing tissue as defined by claim 1, wherein at leastone of the first tissue engagement means and the second tissueengagement means includes a mesh structure.
 12. A device for attaching,relocating or reinforcing tissue as defined by claim 1, wherein at leastone of the first tissue engagement means and the second tissueengagement means includes a resilient pawl, and wherein the connectionmeans includes an elongated member having opposite lateral sides, andratchet teeth situated on at least one of the lateral sides, theresilient pawl of the at least one of the first tissue engagement meansand the second tissue engagement means engaging the ratchet teeth of theconnection means to prevent movement of the connection means withrespect to the at least one of the first tissue engagement means and thesecond tissue engagement means in at least one direction.
 13. A devicefor attaching, relocating or reinforcing tissue as defined by claim 1,which further comprises a third tissue engagement means, the connectionmeans being interposed between and interconnecting the first tissueengagement means, the second tissue engagement means and the thirdtissue engagement means.
 14. A device for attaching, relocating orreinforcing tissue as defined by claim 13, wherein the connection meansincludes a mesh structure extending between the first tissue engagementmeans, the second tissue engagement means and the third tissueengagement means.
 15. A device for attaching, relocating or reinforcingtissue as defined by claim 1, wherein the first tissue engagement meansincludes a first support plate having a first exposed surface, and aplurality of barbs extending angularly outwardly from the first exposedsurface; and wherein the second tissue engagement means includes asecond support plate having a second exposed surface, and a plurality ofbarbs extending angularly outwardly from the second exposed surface, thesecond support plate having formed longitudinally axially therethrough abore for receiving the connection means therethrough.
 16. A device forattaching, relocating or reinforcing tissue as defined by claim 15,wherein the connection means is one of a mesh structure and at least onesuture.
 17. A device for attaching, relocating or reinforcing tissue asdefined by claim 16, wherein the second tissue engagement means includesgripping means for engaging the connection means and for preventingmovement of the connection means with respect to the second tissueengagement means in at least one direction.
 18. A device for attaching,relocating or reinforcing tissue as defined by claim 15, wherein thesecond support plate includes a resilient pawl extending at leastpartially into the axial bore formed in the second support plate, andwherein the connection means includes an elongated member havingopposite lateral sides, and ratchet teeth situated on at least one ofthe lateral sides, the resilient pawl of the second support plateengaging the ratchet teeth of the elongated member to prevent movementof the elongated member with respect to the second support plate in atleast one direction.
 19. A device for attaching, relocating orreinforcing tissue as defined by claim 15, wherein the barbs of thefirst support member are larger that the barbs of the second supportmember.
 20. A device for attaching, relocating or reinforcing tissue asdefined by claim 1, wherein the first tissue engagement means includes asupport plate having an exposed surface, and a plurality of barbsextending angularly outwardly from the exposed surface; wherein thesecond tissue engagement means includes a mesh structure; and whereinthe connection means includes an elongated mesh strip interposed betweenand interconnecting the mesh structure of the second tissue engagementmeans and the support plate of the first tissue engagement means.
 21. Adevice for attaching, relocating or reinforcing tissue as defined byclaim 20, wherein the support plate further has formed longitudinallyaxially therethrough a bore for receiving the elongated mesh strip ofthe connection means therethrough.
 22. A device for attaching,relocating or reinforcing tissue as defined by claim 1, wherein thefirst tissue engagement means includes a support plate having an exposedsurface, and a plurality of barbs extending angularly outwardly from theexposed surface; wherein the second tissue engagement means includes amesh structure; and wherein the connection means includes a sutureinterposed between and interconnecting the mesh structure of the secondtissue engagement means and the support plate of the first tissueengagement means.
 23. A device for attaching, relocating or reinforcingtissue as defined by claim 22, wherein the support plate has formedlongitudinally axially therethrough a bore for receiving the suture ofthe connection means therethrough.
 24. A method of using a device forattaching, relocating or reinforcing tissue, which comprises the stepsof: attaching a first tissue engagement means of at least two tissueengagement means to tissue at a first location; attaching a secondtissue engagement means of the at least two tissue engagement means totissue at a second location, the second location being different fromthe first location, a connection means being interposed between andinterconnecting the first tissue engagement means and the second tissueengagement means; and adjusting the connection means to change thedistance between the first tissue engagement means and the second tissueengagement means.
 25. A method of using a device for attaching,relocating or reinforcing tissue, which comprises the steps of:implanting a first tissue engagement means of at least two tissueengagement means of the device in tissue at a first location; andimplanting a second tissue engagement means of the at least two tissueengagement means in tissue at a second location, the second locationbeing different from the first location, the first tissue engagementmeans and the second tissue engagement means being connected to aconnection means interposed between and interconnecting the first tissueengagement means and the second tissue engagement means.
 26. A minimallyinvasive method for relocating a malar fat pad in a facial plasticsurgery procedure performed on a patient, which comprises the steps of:implanting a soft tissue anchor in the malar fat pad of the patient, thesoft tissue anchor including a support plate having an exposed surfaceand a plurality of barbs extending angularly outwardly from the exposedsurface, the soft tissue anchor being connected to a first portion of asuture; inserting a hollow needle through the subcutaneous cheek tissueand up into the temple of the patient; passing a second portion of thesuture through the hollow needle to the temple of the patient; removingthe hollow needle from the suture; mounting a strong tissue anchor tothe suture at the second portion thereof, the strong tissue anchorincluding a support plate having an exposed surface and a plurality ofbarbs extending angularly outwardly from the exposed surface, andfurther having formed longitudinally axially therethrough a bore forreceiving the second portion of the suture; implanting the strong tissueanchor beneath the temporalis fascia of the patient through a smallincision; and adjusting the suture until the malar fat pad is situatedin a desired location.
 27. A method of using a device for attaching,relocating or reinforcing tissue as defined by claim 14 to support apatient's vaginal vault in a pelvic floor repair surgical procedure,which comprises the steps of: positioning the first tissue engagementmeans and the second tissue engagement means in locations that areanterior and posterior to the patient's vagina in the space between thevagina and the urethra and the space between the vagina and the rectum,respectively; and positioning the third tissue engagement means at alocation near the sacrum and securing the third tissue engagement meansto the periosteum.
 28. A method of using a device for attaching,relocating or reinforcing tissue as defined by claim 14 for surgicallytreating patients with congestive heart failure, which comprises thesteps of: implanting the first tissue engagement means at a location atthe apex of the heart and on the anterior surface thereof; implantingthe second tissue engagement means and the third tissue engagement meansat locations in the atrio-ventricular septum of the heart; and adjustingthe mesh structure with respect to the first tissue engagement means,the second tissue engagement means and the third tissue engagement meansuntil the desired level of ventricular volume change is achieved.
 29. Amethod of using a device for attaching, relocating or reinforcing tissueas defined by claim 14 in order to provide support to the vagina inpelvic organ prolapse repair, which comprises the steps of: placing themesh structure anterior and posterior to the vagina through atransvaginal incision or through an endoscopic approach; implanting thefirst tissue engagement means, the second tissue engagement means andthe third tissue engagement means at locations near the entroitus andinto the sacrospinus ligament or the periosteum near the sacrum; andadjusting the mesh structure to provide the appropriate placement of thevaginal vault.